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Revision History

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Asthma Nighttime Symptom Diary V1.0 0 (ANSD V1.0) instrument.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

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Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

2 Copyright Status

Critical Path Institute owns the copyright for the ANSD V1.0 instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements.  Hence, CDISC developed QSTESTCD developed QSTESTCD and QSTEST for QSTEST for each item based on the actual text on the instrument. 

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges the Critical the Critical Path Institute for the approval to include the ANSD V1.0 in the CDISC data standards.

References for the ANSD V1.0:

• Version 1.0 Copyright 2018 Critical Path Institute. All Rights Reserved.
• Gater A, Nelsen L, Fleming S, Lundy J.J, Bonner N, Hall R, Marshall C, Staunton H, Krishnan JA, Stoloff S, Schatz M, Haughney J on behalf of the Patient-Reported Outcome Consortium’s Asthma Working Group. Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the Asthma Daily Symptom Diary. Value in Health 2016; 9:440-450).
  

3 TheQSDomain Model

3.1 Assumptions for theQSDomain Model

All assumptions and business rules described in the SDTMIG QS SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the ANSD V1.0 are listed below.

The ANSD V1.0 is a 6-item PRO measure to assess self-reported severity of asthma symptoms during the night. Each item is rated on an 11-point numeric rating scale. A total score is also represented as described in the manual.

1. The scale points include a 0 to 10 rating with 0 = "None", 10 = "As bad as you can imagine", and all points in between only having a numeric value. For the ANSD V1.0, QSORRES is populated with the text description for "None" and "As bad as you can imagine" and the numeric value for all other answers, while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

2. The time period of evaluation for the ANSD V1.0 is populated in the QSEVINTXthe QSEVINTX when the evaluation interval can be precisely described as duration. The evaluation interval for the ANSD V1.0 is 0 is since you went to bed last night (QSEVINTX = "SINCE GOING TO BED").

3. The ANSD The ANSD V1.0 instrument includes a total 0 instrument includes a total score that is not collected on the ANSD the ANSD v1.0 CRF but 0 CRF but is described in the manual, that is considered is considered as captured data on the CRF and is not considered as derived in the example below.

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to Y. However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

4. Terminology

   1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the ANSD V1.0 QS Domain Model

The ANSD V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the ANSD V1.0 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRESQSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

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in QSSTRESC.

The table represents the items from the ANSD V1.0 instrument as 0 instrument as well as the total score. Rows 8-14 show how to represent data when the entire instrument was not done due to the subject refusing the test.

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSTESTCD="ANSD0101" QSTEST="ANSD01-Rate Breathing at Its Worst" through

QSTESTCD="ANSD0106" QSTEST="ANSD01-Rate Cough at Its Worst"

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